MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; ARTHROSCOPE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Literature citation: hiroki yasuoka, takashi asazuma, hideaki imabayashi, hiroko shimizu "effect of combined administration of terip aratide on balloon kyphoplasty".(b)(4).

Event Description

It was reported in an abstract that total of 30 patients with delayed union after osteoporotic thoracolumbar vertebral fracture who were followed up for more than six months with everyday dose of teriparatide underwent bkp from (b)(6) 2012 to (b)(6) 2014.As post op complication, in one patient at the final follow up after 15 months from the operation,minor collapse of the upper disc after bkp and the end plate were confirmed on images."back pain has no interfere with patient¿s daily routine.".

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6204462
• MDR Text Key: 63258259
• Report Number: 1030489-2016-03523
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: 12/02/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR